Simultaneously Integrated Dose Escalation for Locally Advanced Cervical Cancer

NCT ID: NCT02879214

Last Updated: 2018-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2020-02-29

Brief Summary

The purpose of this study is to determine the feasibility of minimal invasive surgical resection through simultaneously integrated dose escalation given concurrently with chemotherapy for locally advanced squamous cell cervical cancer.

Detailed Description

Concurrent radiation therapy and chemotherapy is the standard of care for locally advanced cervical cancer. While there are several acceptable means to boost the disease in the low pelvis (i.e. brachytherapy, IMRT, or external beam), there is limited research into minimal invasive surgical resection after maximal downstage. This protocol is designed to determine the dose escalation of both chemo and radiation for treating tumor bearing regions within the abdomen and pelvis, using an two drug chemotherapy in first cycle of mitomycin/cisplatin or taxol/cisplatin along with simultaneously integrated boost technique to Biological target area defined by PET scan. This dose escalation is to downstage disease for minimal invasive surgical resection.

Conditions

Squamous Cell Carcinoma of Cervix

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SIDE cervical trial

To Maximal downstage locally advanced squamous cell cervical cancer before minimal invasive surgical resection. The SIDE study is to use both RT dose escalation to the biological target defined by PET and Chemo dose escalation composited with two drugs to achieve maximal reduction of tumor burden, providing feasibility of minimal invasive surgical resection.

Group Type: EXPERIMENTAL

Simultaneous boost along with chemo

Intervention Type: RADIATION

Prior studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3), the studies often use single drug. This study treatment plan will use dose intensify in both chemotherapy and radiation. The chemotherapy have two drugs regimens of mitomycin with cisplatin or taxol with cisplatin along of radiation dose escalate, the RT dose escalation to biological GTV defined by PET scan to dose of 57.50 Gy in 25 fx while the elective volumes are held constant at 45 Gy.

Interventions

Simultaneous boost along with chemo

Prior studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3), the studies often use single drug. This study treatment plan will use dose intensify in both chemotherapy and radiation. The chemotherapy have two drugs regimens of mitomycin with cisplatin or taxol with cisplatin along of radiation dose escalate, the RT dose escalation to biological GTV defined by PET scan to dose of 57.50 Gy in 25 fx while the elective volumes are held constant at 45 Gy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Biopsy confirmed squamous cell carcinoma of cervix, able to receive chemotherapy and concurrent chemoradiotherapy.

Good performance status. Negative pregnancy test in women of child-bearing potential. Signed study-specific informed consent. Lab results within study specific limits

Exclusion Criteria

• Prior radiation to the abdomen or pelvis. A history of Scleroderma or Inflammatory bowel disease. Contraindication to chemotherapy or radiation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

ming zeng, MD

Director of Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Zeng, MD PhD

Role: STUDY_CHAIR

Sichuan Provincial People Hospital, Sichuan Academy of Medical Sciences

Locations

Sichuan PPH, Departmentn of Gynecology Oncology

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Ming Zeng, MD PhD

Role: CONTACT

miller2002@yahoo.acom

086-17708131336

Haixia Pan, MD

Role: CONTACT

086-18981838380

Facility Contacts

Lan Xie, MD

Role: primary

086-87398097

Yi Liu, MD

Role: backup

086-87398097

Other Identifiers

201604

Identifier Type: -

Identifier Source: org_study_id